Pacific Edge awarded patent in Singapore
Pacific Edge awarded patent for colorectal cancer prognostic technology in Singapore
Pacific Edge (the “Company”) has recently been awarded a patent in Singapore for its colorectal cancer prognostic technology and anticipates that the patent will issue in other targeted countries over the next 12 to 24 months.
Globally, colorectal cancer (CRC) is the fourth most common cancer. In 2007 there were 1,000,000 cases diagnosed worldwide and 520,000 people died of the disease. The American Cancer Society estimates that there were 148,000 new cases of CRC diagnosed and 49,000 people died of this disease in the United States in 2008.
The Company’s colorectal cancer prognostic technology enables the detection of aggressive cancer in patients already diagnosed with colorectal cancer. This prognostic test is expected to provide clinicians with a significantly improved opportunity to determine the aggressiveness of the patient’s Stage II and Stage III colorectal cancer. The test enables physicians to predict colorectal cancer progression and thereby provide their patients with a more specific treatment following surgery. Pacific Edge’s colorectal cancer prognostic gene signature is the second commercial product for the Company and it joins the Company’s recently commercially launched bladder cancer detection test Cxbladder®.
Pacific Edge announced the successful completion of a European clinical trial for the prognostic gene signature for colorectal cancer in June 2010 when the results were released at the annual scientific meeting of the American Society for Clinical Oncology (ASCO), by Signature Diagnostics. The positive results from the international, multi-center study demonstrate the capability of the Company’s colorectal cancer technology in distinguishing between patients at high-risk or low-risk of disease progression.
Presently, patients with Stage II disease are generally not treated with adjuvant chemotherapy because it is not possible to identify the subset of patients who will have progressive disease. In the five major European countries and the USA, approximately 400,000 individuals are diagnosed with CRC every year. Of these diagnosed cases, 280,000 patients are diagnosed with Stage II and Stage III CRC. Approximately 30% of the patients with Stage II and roughly 50% of those with Stage III experience disease progression including distant metastasis of the liver and lung or local recurrence within three to five years after surgery. If the cancer spreads to distant organs, the five-year survival rate for these patients is approximately 8% making the early detection of those patients with an aggressive disease a significant medical breakthrough. The Pacific Edge prognostic gene signature will provide clinicians with a valuable tool to help identify these patients at greatest risk who will then be able to be targeted for adjuvant chemotherapy in addition to surgery.
Pacific Edge raising funds to roll-out bladder cancer test into the US
The Company is currently underway with a $16 million pro-rata renounceable entitlement offer to eligible shareholders (“Entitlement Offer”). The proceeds of the Entitlement Offer, together with the proceeds of the Company’s recently successfully completed $5.1 million share placement, will provide the Company with the funding to commercialise its flagship bladder cancer test, Cxbladder® in the United States.
Building on the momentum gained from recently announced licensing agreements with Healthscope in Australia and Oryzon in Spain, the Company now plans to deliver Cxbladder® as a Laboratory Developed Test (LDT) to United States clinicians. The test will be performed in a CLIA certified laboratory in Hershey, Pennsylvania. There are approximately 58 million people on the eastern seaboard of the US and the proposed laboratory will be cited within a two-hour average drive time of several large US cities. Following completion of the CLIA laboratory and CLIA licensing in Pennsylvania, the Company will commercialise Cxbladder® targeting initially the large private practices of urologists across the US with the tests all being performed in the Company’s proposed new central laboratory in Hershey.
Bladder cancer is the fourth most expensive cancer to treat and incurs the highest total medical cost per patient of all cancers: ~US$200,000 from diagnosis to death. In the US, bladder cancer is the sixth most prevalent (8% of male cancers and 2% of female).
Cxbladder® is a non-invasive, accurate test that enables the early detection of bladder cancer from a small volume of urine. It provides general practitioners and urologists with a quick, cost effective and accurate measure of the presence of the cancer, and provides urologists with the opportunity to reduce their reliance on the need for invasive tests such as cystoscopy. The recently completed multi-centre, international clinical study recruited 467 patients from Australia and New Zealand. Results show that Cxbladder® outperforms all of the benchmark technologies in the trial and detected nearly all of the tumours of concern to a urologist; greater than 95% of all late stage and greater than 95% of high grade tumours. It is anticipated that Cxbladder® will replace cytology as the test of choice in the clinicians urological work-up for detection of bladder cancer and the test of choice to compliment the use of cystoscopy in the monitoring of patients for recurrence of the disease.